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BioLineRx Reports Year End 2018 Financial Results and Provides Corporate Update
BL-8040 and AGI-134 oncology programs progressing, with multiple data read-outs expected in the next 12 months
Management to hold conference call today, March 28, at 10:00 am EDT

TEL AVIV, Israel, March 28, 2019 /PRNewswire/ -- BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology, today reports its financial results for the year ended December 31, 2018 and provided a corporate update.

Highlights and achievements during the fourth quarter 2018 and subsequent period:

  • Presented data from Phase 2a COMBAT/KEYNOTE-202 pancreatic cancer study in collaboration with Merck at the ESMO 2018 Congress demonstrating that BL-8040 in combination with KEYTRUDA® (pembrolizumab) showed encouraging disease control and overall survival in patients with metastatic pancreatic cancer; compelling pharmacodynamic data also demonstrated T-cell infiltration into tumors and a reduction of the tumor immuno-suppressive microenvironment;
  • Initiated a triple combination arm of COMBAT/KEYNOTE-202 evaluating the safety, tolerability and efficacy of BL-8040 in combination with KEYTRUDA and chemotherapy;
  • Entered into agreement with Biokine Therapeutics to increase the Company's economic stake in BL-8040 to 80% from the previous level of 60%;
  • Initiated Phase 1/2a multicenter, open-label clinical study in the UK and Israel for AGI-134, a novel immunotherapy evoking a direct anti-tumor response and vaccine effect for the treatment of solid tumors;
  • Announced FDA Orphan Drug Designation for BL-8040, for the treatment of pancreatic cancer. This is in addition to prior orphan drug designations received for BL-8040 in AML and stem cell mobilization;
  • Announced FDA Biological Product Designation for AGI-134, providing the Company with eligibility to obtain 12 years of market exclusivity upon approval of the product for commercial use by the FDA; and
  • Completed an underwritten public offering for gross proceeds of $15.4 million.

"During the fourth quarter, we continued to advance our novel pipeline of promising anti-cancer therapies toward significant and potentially value-creating milestones, and this progress was a key driver in our previously announced decision to acquire an additional 20% economic stake in BL-8040 from Biokine Therapeutics," said Philip Serlin, Chief Executive Officer of BioLineRx. "In cancer immunotherapy, following the encouraging results we announced from the dual combination arm, we initiated the triple combination arm of the COMBAT/KEYNOTE-202 study evaluating our lead therapeutic candidate, BL-8040, in combination with Merck's KEYTRUDA and chemotherapy for the treatment of metastatic pancreatic cancer, an indication for which we also recently received FDA Orphan Drug Designation."  

"In stem-cell mobilization, our most advanced indication, we continue to move forward with the Phase 3 GENESIS study in the randomized placebo-controlled phase of the trial, and we hope that we will be able to replicate the compelling results observed in the lead-in portion of the trial. Concurrently, in relapsed/refractory AML, we are evaluating our future development plan, and anticipate meeting with the regulatory authorities to discuss the plan during the second half of this year. In consolidation AML, we hope to announce interim data from the large, randomized placebo-controlled Phase 2b BLAST study by the end of this year as well."

"Finally, our second oncology program, the cancer immunotherapy vaccine AGI-134, is also progressing as planned, with initial safety data from the ongoing Phase 1/2a study expected later this year. As we progress through 2019, we are rapidly approaching important data readouts that we believe can create significant shareholder value and additional partnering interest, and we look forward to providing future updates throughout the year."

Expected significant milestones through end of 2019 and early 2020:

  • Top-line results from the Phase 2 triple combo pancreatic cancer trial of BL-8040, KEYTRUDA and chemotherapy under collaboration with Merck toward the end of 2019;
  • Potential interim results from Phase 2 AML consolidation study in the second half of 2019;
  • Initial safety results from part 1 of Phase 1/2a trial for AGI-134 in second half of 2019;
  • Top-line results from one or more of the solid tumor trials under collaboration with Genentech, potentially by end of 2019 or early 2020.

Financial Results for the Year Ended December 31, 2018 

Research and development expenses for the year ended December 31, 2018 were $19.8 million, an increase of $0.3 million, or 1.5%, compared to $19.5 million for the year ended December 31, 2017. The small increase resulted primarily from an increase in share-based compensation.

Sales and marketing expenses for the year ended December 31, 2018 were $1.4 million, a decrease of $0.3 million, or 19.6%, compared to $1.7 million for the year ended December 31, 2017. The decrease resulted primarily from one-time legal fees related to AGI-134, as well as market research for BL-8040 and AGI-134, incurred in the 2017 period.

General and administrative expenses for the year ended December 31, 2018 were $4.4 million, an increase of $0.4 million, or 9.9% compared to $4.0 million for the year ended December 31, 2017. The increase resulted primarily from an increase in share-based compensation.

The Company's operating loss for the year ended December 31, 2018 amounted to $25.6 million, compared with an operating loss of $25.2 million for the year ended December 31, 2017.

Non-operating income amounted to $2.4 million for the year ended December 31, 2018, compared with non-operating expenses of $0.3 million for the year ended December 31, 2017. Non-operating income for the year ended December 31, 2018 primarily relates to fair-value adjustments of warrant liabilities and a capital gain from realization of the investment in iPharma. Non-operating expenses for the year ended December 31, 2017 primarily relate to fair-value adjustments of warrant liabilities.

Net financial income amounted to $0.2 million for the year ended December 31, 2018 compared to net financial income of $1.1 million for the year ended December 31, 2017. Net financial income for the year ended December 31, 2018 primarily relates to investment income earned on bank deposits, offset by interest paid on loans. Net financial income for the year ended December 31, 2017 relates primarily to gains recorded on foreign currency hedging transactions and investment income earned on bank deposits.

The Company's net loss for the year ended December 31, 2018 amounted to $23.0 million, compared with a net loss of $24.4 million for the year ended December 31, 2017.

The Company held $30.2 million in cash, cash equivalents and short-term bank deposits as of December 31, 2018. Subsequent to year end, the Company raised $15.4 million of gross proceeds from an underwritten public offering.

Net cash used in operating activities for the year ended December 31, 2018 was $24.2 million, compared to $20.5 million for the year ended December 31, 2017. The $3.7 million increase in 2018 was the result of a decrease in accounts payable and an increase in prepaid expenses and other receivables.

Net cash provided by investing activities for the year ended December 31, 2018 was $9.6 million, compared to net cash used in investing activities of $15.9 million for the year ended December 31, 2017. The changes in cash flows from investing activities relate primarily to investments in, and maturities of, short-term bank deposits during both periods, the acquisition of Agalimmune in 2017, and the acquisition of an additional 20% of BL-8040 sublicense receipts, as well as realization of the investment in iPharma, during 2018.

Net cash provided by financing activities for the year ended December 31, 2018 was $13.1 million, compared to $38.7 million for the year ended December 31, 2017. The cash flows in 2018 primarily reflect the net proceeds of the loan from Kreos Capital, as well as net proceeds from the ATM program. The cash flows in 2017 primarily reflect the underwritten public offering of our ADSs in March 2017 and the direct placement of ADSs and warrants to BVF Partners in July 2017.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, March 28, 2019 at 10:00 a.m. EDT. To access the conference call, please dial +1-866-229-7198 from the U.S. or +972-3-918-0664 internationally. The call will also be available via webcast and can be accessed through the Investor Relations page of BioLineRx's website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast.

A replay of the conference call will be available approximately two hours after completion of the live conference call on the Investor Relations page of BioLineRx's website. A dial-in replay of the call will be available until March 30, 2019; please dial +1-888-295-2634 from the U.S. or +972-3-925-5938 internationally.

(Tables follow)

About BioLineRx

BioLineRx is a clinical-stage biopharmaceutical company focused on oncology. The Company in-licenses novel compounds, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx's leading therapeutic candidates are: BL-8040, a cancer therapy platform, which has successfully completed a Phase 2a study for relapsed/refractory AML, is in the midst of a Phase 2b study as an AML consolidation treatment and has initiated a Phase 3 study in stem cell mobilization for autologous transplantation; and AGI-134, an immunotherapy treatment in development for multiple solid tumors, which has recently initiated a Phase 1/2a study. In addition, BioLineRx has a strategic collaboration with Novartis for the co-development of selected Israeli-sourced novel drug candidates; a collaboration agreement with MSD, on the basis of which the Company is conducting a Phase 2a study in pancreatic cancer using the combination of BL-8040 and KEYTRUDA® (pembrolizumab), and a collaboration agreement with Genentech, a member of the Roche Group, to investigate the combination of BL-8040 and Genentech's atezolizumab in several Phase 1b/2 studies for multiple solid tumor indications and AML.

For additional information on BioLineRx, please visit the Company's website at www.biolinerx.com, where you can review the Company's SEC filings, press releases, announcements and events. BioLineRx industry updates are also regularly updated on FacebookTwitter, and LinkedIn.

Various statements in this release concerning BioLineRx's future expectations constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as "may," "expects," "anticipates," "believes," and "intends," and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the "Risk Factors" section of BioLineRx's most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 28, 2019. In addition, any forward-looking statements represent BioLineRx's views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

 

BioLineRx Ltd.

CONSOLIDATED STATEMENTS OF FINANCIAL POSITION

 



December 31,



2017


2018



in USD thousands

Assets





CURRENT ASSETS





Cash and cash equivalents


5,110


3,404

Short-term bank deposits


44,373


26,747

Prepaid expenses


307


488

Other receivables


586


1,339

          Total current assets


50,376


31,978






NON-CURRENT ASSETS





Long-term prepaid expenses


61


56

Long-term investment


1,000


-

Property and equipment, net


2,505


2,227

Intangible assets, net


7,023


21,972

          Total non-current assets


10,589


24,255

          Total assets


60,965


56,233






Liabilities and equity





CURRENT LIABILITIES





Current maturities of long-term loans


93


895

Accounts payable and accruals:





     Trade


5,516


4,493

     Other


1,113


1,363

          Total current liabilities


6,722


6,751






NON-CURRENT LIABILITIES





Long-term loans, net of current maturities


157


7,838

Warrants


1,205


323

          Total non-current liabilities


1,362


8,161






COMMITMENTS AND CONTINGENT LIABILITIES





          Total liabilities


8,084


14,912






EQUITY





Ordinary shares


2,836


3,110

Share premium


240,682


250,192

Capital reserve


10,337


11,955

Other comprehensive loss


(1,416)


(1,416)

Accumulated deficit


(199,558)


(222,520)

          Total equity


52,881


41,321

          Total liabilities and equity


60,965


56,233

 

 

 

BioLineRx Ltd.

CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS




Year ended December 31,



2016


2017


2018



in USD thousands

RESEARCH AND DEVELOPMENT EXPENSES


(11,177)


(19,510)


(19,808)

SALES AND MARKETING EXPENSES


(1,352)


(1,693)


(1,362)

GENERAL AND ADMINISTRATIVE EXPENSES


(3,984)


(4,037)


(4,435)

OPERATING LOSS


(16,513)


(25,240)


(25,605)

NON-OPERATING INCOME (EXPENSES), NET


214


(260)


2,397

FINANCIAL INCOME


480


1,169


719

FINANCIAL EXPENSES


(22)


(21)


(473)

NET LOSS AND COMPREHENSIVE LOSS


(15,841)


(24,352)


(22,962)










in USD

LOSS PER ORDINARY SHARE – BASIC AND DILUTED


(0.28)


(0.27)


(0.21)








WEIGHTED AVERAGE NUMBER OF SHARES USED IN
    CALCULATION OF LOSS PER ORDINARY SHARE


56,144,727


89,970,713


108,595,702


 

 

 


BioLineRx Ltd.

STATEMENTS OF CHANGES IN EQUITY


Ordinary
shares


Share
premium


Capital
reserve


Other
comprehensive
 loss 


Accumulated
deficit


Total


in USD thousands

BALANCE AT JANUARY 1, 2016

1,455


196,201


10,735


(1,416)


(159,365)


47,610

CHANGES IN 2016:












  Issuance of share capital, net

57


2,126


-


-


-


2,183

  Employee stock options exercised

1


171


(172)


-


-


-

  Employee stock options expired

-


1,069


(1,069)


-


-


-

  Share-based compensation   

-


-


1,075


-


-


1,075

  Comprehensive loss for the year

-


-


-


-


(15,841)


(15,841)

BALANCE AT DECEMBER 31, 2016

1,513


199,567


10,569


(1,416)


(175,206)


35,027

CHANGES IN 2017:












  Issuance of share capital, net

1,322


39,376


-


-


-


40,698

  Employee stock options exercised

1


328


(329)


-


-


-

  Employee stock options expired

-


1,411


(1,411)


-


-


-

  Share-based compensation   

-


-


1,508


-


-


1,508

  Comprehensive loss for the year

-


-


-


-


(24,352)


(24,352)

BALANCE AT DECEMBER 31, 2017

2,836


240,682


10,337


(1,416)


(199,558)


52,881

CHANGES IN 2018:












  Issuance of share capital, net

263


8,567


-


-


-


8,830

  Employee stock options exercised

11


415


(380)


-


-


46

  Employee stock options expired

-


528


(528)


-


-


-

  Share-based compensation   

-


-


2,526


-


-


2,526

  Comprehensive loss for the year

-


-


-


-


(22,962)


(22,962)

BALANCE AT DECEMBER 31, 2018

3,110


250,192


11,955


(1,416)


(222,520)


41,321

 

 

 

BioLineRx Ltd.

CONSOLIDATED CASH FLOW STATEMENTS



Year ended December 31,


2016


2017


2018


in USD thousands

CASH FLOWS - OPERATING ACTIVITIES






     Net loss

(15,841)


(24,352)


(22,962)

     Adjustments required to reflect net cash used in operating
             activities (see appendix below)

1,328


3,805


(1,230)

Net cash used in operating activities

(14,513)


(20,547)


(24,192)







CASH FLOWS - INVESTING ACTIVITIES






     Increase in long-term investment

-


(1,000)


-

     Realization of long-term investment





1,500

     Investments in short-term deposits

(32,982)


(44,016)


(26,500)

     Maturities of short-term deposits

42,334


33,327


44,771

     Purchase of property and equipment

(52)


(338)


(173)

     Purchase of intangible assets

(3)


(3,900)


(10,043)

Net cash provided by (used in) investing activities

9,297


(15,927)


9,555







CASH FLOWS - FINANCING ACTIVITIES






     Issuance of share capital and warrants, net of issuance costs

2,183


38,773


3,830

     Employee stock options exercised

-


-


46

     Proceeds of long-term loan and warrants, net of issuance
             costs

-


-


9,632

     Repayment of long-term loan

-


-


(318)

     Repayments of bank loan

(93)


(93)


(93)

Net cash provided by financing activities

2,090


38,680


13,097







INCREASE (DECREASE) IN CASH AND CASH
   EQUIVALENTS

(3,126)


2,206


(1,540)

CASH AND CASH EQUIVALENTS - BEGINNING

   OF YEAR

5,544


2,469


5,110

EXCHANGE DIFFERENCES ON CASH AND CASH
   EQUIVALENTS

51


435


(166)

CASH AND CASH EQUIVALENTS - END OF YEAR

2,469


5,110


3,404







 

 

 

BioLineRx Ltd.

CONSOLIDATED CASH FLOW STATEMENTS



Year ended December 31,


2016


2017


2018


in USD thousands

APPENDIX












Adjustments required to reflect net cash used in operating
      activities:






Income and expenses not involving cash flows:






Depreciation and amortization

482


481


545

Long-term prepaid expenses

6


(9)


5

Exchange differences on cash and cash equivalents

(51)


(435)


166

Loss (gain) on adjustment of warrants to fair value

(207)


127


(1,743)

Share-based compensation

1,075


1,508


2,526

Interest and exchange differences on short-term deposits

(387)


(530)


(645)

Interest and linkage differences on loans

(1)


-


123

Gain on realization of long-term investment

-


-


(500)

Warrant issuance costs

-


17


-


917


1,159


477







Changes in operating asset and liability items:






Decrease (increase) in prepaid expenses and other
  receivables

42


(415)


(934)

Increase (decrease) in accounts payable and accruals

369


3,061


(773)


411


2,646


(1,707)








1,328


3,805


(1,230)



















Supplemental information on interest received in cash

453


494


834

Supplemental information on non-cash transactions

-


2,985


5,000


 

Contact:
Tim McCarthy
LifeSci Advisors, LLC
+1-212-915-2564
tim@lifesciadvisors.com 

or

Tsipi Haitovsky
Public Relations
+972-52-598-9892
tsipihai5@gmail.com 

Cision View original content:http://www.prnewswire.com/news-releases/biolinerx-reports-year-end-2018-financial-results-and-provides-corporate-update-300820172.html

SOURCE BioLineRx Ltd.


Interview with Philip Serlin, CEO
December 2016